Vaccines, Blood & Biologics
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Recalls (Biologics)
Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Market Withdrawals are a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation.
The most recent action is added to the top of the list. Dates refer to the effective date of the recall, withdrawal, correction, or notification.
Recalls older than 5 years have been archived and can be obtained by placing a Freedom of Information (FOI) Request.
2010 Biologics Recalls
Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5 Market Withdrawal of GAMMAGARDLIQUID, Immune Globulin Intravenous (Human) Important Notice RabAvert Rabies Vaccine (Rabies Vaccine for Human Use) Kits Important Information Regarding Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating Recall of AMICUS Ancillary PL2410 Plastic Storage Container 4R2350 Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth Market Withdrawal of Chiron RIBA HCV 3.0 SIA Recall of Influenza A (H1N1) 2009 Monovalent Vaccine Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine in Prefilled Syringes Recall: Y-Type Blood Solution Sets Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating
2009 Biologics Recalls
Recall: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Recall: Influenza A (H1N1) 2009 Monovalent Vaccine - Lot Numbers UT023DA, UT028CB, UT028DA, and UT030CA Recall: T.R.U.E. Test Box Lot 94009 Urgent Medical Device Removal: COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor Test Important Information: Donor Management System (DMS) Blood Management Computer System Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth Recall: Haemonetics List No. 620 PCS2 Plasma Harness Set, Haemonetics Corporation Medical Device Recall (PR09-0082-0): Cerner PathNet Blood Bank Donor, Cerner Corporation Urgent Instruction Correction: Biotest Tango Automated Blood Bank Analyzer, Biotest AG-Dreieich Urgent Notification: Package Insert Update for MLB2 Modified LISS Solution - Biotest AG Important Notification: FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes - Novartis Vaccines and Diagnostics Limited
2008 Biologics Recalls
Field Correction for Component Pack packaged with Mononine (Coagulation Factor IX, Human)-CSL Behring Urgent Medical Device Removal – AXP Processing Bagset-ThermoGenesis Medical Device Notification (PSN-08-09)-Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc. Important Notification: Red Cell Collection Kits-Haemonetics Corporation Recall of m2000sp Instrument-Abbott Molecular, Inc. Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit) ] - Genzyme Corporation Recall: Antihemophilic Factor, Human - CSL Behring L.L.C. Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc. Medical Device Notification (PSN-08-08) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc. Recall of m2000sp Instrument-Abbott Molecular Medical Device Notification (PSN-08-05) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest InformationSystems, Inc. Correction of AUSZYME Monoclonal Assay-Abbott Laboratories Urgent Product Correction - Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test - Bio-Rad Laboratories Medical Device Notification (PSN-08-03) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc. Medical Device Recall: BioArchive (Vapor Bypass Assembly)-Thermogenesis Corporation Withdrawal of Albumin (Human) 5 %-Talecris Biotherapeutics Product Correction: Hepatitis B Surface Antigen AUSAB EIA-Abbott Laboratories Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc Recall of Rho(D) Immune Globulin (Human); Hyper RHO S/D, Mini-Dose-Talecris Biotherapeutics, Inc Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]-Genzyme Corporation Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc Medical Device Notification: Filtered Red Cell Disposable Kits-Haemonetics Corporation Recall of ThermoGenesis AXP Bag Sets 8-5101-ThermoGenesis Corporation Recall of Uni-Gold Recombigen HIV-Trinity Biotech USA Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc. Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]-Genzyme Corporation-2/11/08 Recall of Hymenoptera (Honey Bee) Venom Products - Hollister-Stier Laboratories Recall of Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2-Sunquest Information Systems, Inc. Recall of White-Faced Hornet Venom Protein - Hollister-Stier Laboratories LLC
2007 Biologics Recalls
Market Withdrawal of Octagam-Octapharma USA Inc. Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, Inc Recall of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]-Merck & Co., Inc. Recall of Tubing Sets used with COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood Collection Systems-Gambro BCT, Inc. Important Notification: Blood Grouping Reagent Anti-Lea BioClone 2.0-Ortho Clinical Diagnotics, Inc. Recall of CROFAB (Crotalidae Polyvalent Immune Fab (Ovine)-Protherics Medical Device Notification: Data Innovations Instrument Manager-Data Innovations, Inc. Medical Device Notification: TERUFLEX CPDA-1 Blood Bag System-Terumo Medical Corporation Field Correction of Transfer Sets Packed with Humate-P - CSL Behring LLC Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets-Smiths Medical ASD, Inc. Recall of CS3000 Apheresis Kits-Fenwal, Inc. Recall of m2000sp and m1000 Instrument-TECAN Schweiz AG / Abbott Molecular, Inc. Recall of Bean, String Green Allergenic Extract-Alk Abello Market Withdrawal of LAL Reagent - Associate of Cape Cod Recall of Medical Devices - Biomet Biologics, Inc Important Notification: Fast Flow Fluid Warmers-Smiths Medical Biological Product Withdrawal of Carimune NF Immune Globulin Intravenous-ZLB Behring Recall of FETALSCREEN - Ortho-Clinical Diagnostics
2006 Biologics Recalls
Notification of BacT/VIEW C.30a Software Update-bioMerieux, Inc. Notification of BacT/VIEW Software (all versions)-bioMerieux, Inc. Recall of Vironostika HIV-1 Microelisa System-bioMerieux, Inc. Recovery Notice - Fluvirin (Influenza Virus Vaccine)-Novartis Vaccines and Diagnostics Limited/Cardinal Health Care Recall of Dupaco Blood/Fluid Warming Set-Dupaco, Inc. Recall of Home Access and Home Access Express HIV-1 Test System-Home Access Health Corporation Field Action Notification - Becton Dickinson (BD) Procount Kit-BD Biosciences Important Drug Information - Antihemophilic Factor (Human), Koate DVI-Talecris Biotherapeutics Important Drug Information - Antihemophilic Factor (Human), Koate DVI (3 lots)-Talecris Biotherapeutics Recall of RAD-SURE Blood Irradiation Indicators-International Specialty Products / Kent Adhesive Products Company Important Customer Notification - Vironostika HIV-1 - bioMerieux Recall of BD CMVScan Card Test Kit-Becton Dickinson Diagnostics Recall of Decavac Vaccine-Amerisource Bergen / Sanofi Pasteur, Inc. Medical Device Recall - Ranger High Flow Blood / Fluid Warming Disposable Sets-Biotest Laboratories, Inc. / Arizant, Inc. Field Correction: Galileo Blood Bank Analyzer-Immucor, Inc Medical Device Notification - Misys Laboratory Blood Bank Module, Version 6.1-Misys Healthcare Systems Recall of Allergenic Extracts-Greer Laboratories Field Correction - Medi-Temp III, Blood and Fluid Warmer-Gaymar Industries, Inc. Device Correction: Operator’s Manual for Baxter Fenwal Amicus Separator-Baxter Healthcare Corp
2005 Biologics Recalls
Notice of Field Correction: Haemonetics MCS+ 9000, Cell Saver 5, Cell Saver 5+-Haemonetics Corp Recall of Charter Medical Transfer Bags-Charter Medical, Ltd Recall of LCG2 Leukoreduction System for Red Blood Cells-MacoProductions S.A.S. Recall of Baxter ALYX Red Kit Disposables-Baxter Healthcare Corp FDA Provides Information on Investigation into Human Tissue for Transplantation Recall of Human Tissue Products-Regeneration Technologies, Inc Recall of Human Tissue-Biomedical Tissue Services, Ltd Medical Device Notification Transfer Set with 150 Micron Filter-Charter Medical Recall of Human Tissue Products-Tutogen Medical, Inc Recall of Human Tissue Products-The Blood and Tissue Center of Central Texas Recall of Plasma Protein Fraction, Plasmanate-Talecris Biotherapeutics Withdrawal of Human Tissue Products-Lost Mountain Tissue Bank Recall of Human Tissue Products-LifeCell Corp Recall of Albumin (Human) 25 %, Albuminar (Updated)-ZLB Behring LLC Recall of Albumin (Human) 25 %, Albuminar, ZLB Behring LLC Medical Device Notification: Hotline L-10 Gas Vent-Smiths Medical ASD, Inc Recall of Level 1 H-31B Air Detector/Clamping Devices, Level 1 H-1200 Fast Flow Fluid Warmers-Smiths Medical ASD, Inc Recall of Hemoflow Model 300-Applied Science, Inc Medical Device Notification: 150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor-Charter Medical, Ltd. Medical Device Notification: Misys Laboratory Blood Bank and Blood Donor, Version 6.1-Misys Healthcare System Urgent Product Correction: Six-Part BarCode Labels for Sarstedt Tubes-Roche Diagnostics Corporation, Inc. Recall of Platelet Sampling Device-Charter Medical Ltd Recall of CPDA-1 Quadruple Blood-Pack Unit, Baxter Blood-Pack Unit (BPU) with Samplink Access Device-Baxter Healthcare Corp Device Correction of Baxter Amicus Separator-Baxter Healthcare Corp Recall of Sepacell PLS-5A Platelet Leukoreduction Filter with Administration Set, Platelet Bedside Filter-Baxter Healthcare Corp Medical Device Notification: HNA Classic 306 Patient Manager Blood Bank Software-Cerner Corp Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System-Haemonetics Corp Medical Device Notification: StemCXP Software, Version 1.0-Beckman Coulter, Inc Recall of Additional Lot of Leukocyte Reduction BPF4 High Efficiency Filter-Pall Medical Corp 12/17/2004 Recall Notice Notice of Field Correction: Sorvall Cellwasher 2, Cell Washing System-Kendro Laboratory Products Important Product Information - Correction - Corzyme-Abbott Laboratories Recall of Rapid HIV Test Kits-Globus Media, Inc FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper Unapproved Home-Use Diagnostic Kits Marketed by Globus Media-Medwatch Recall of Amicus Apheresis Kits-Baxter Healthcare Corporation Recall of Modified Alsever's Solution, Blood Cell Diluent-Gamma Biologicals Recall of Blood Bank Devices-Charter Medical, Ltd. Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics Market Withdrawal of HIV-1 / HCV Assay-Procleix - Gen-Probe Inc Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics
2004 Biologics Recalls
Recall of Leukocyte Reduction BPF4 High Efficiency Filter- Pall Medical Corp Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems Update-Haemonetics Corp Notice of Field Correction: Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System-Haemontics Corp Recall of ORTHO Antibody to HBsAg ELISA Test System 3-Ortho Clinical Diagnostics Recall of Trima Accel LRS Tubing Sets-Gambro BCT, Inc Recall of Amicus Separator Apheresis Device-Baxter Healthcare Corp Recall of Limulus Amebocyte Lysate (LAL), Pyrotell-Associates of Cape Cod, Inc Recall of Amplicor HIV-1 Monitor Test, v 1.5-Roche Molecular Systems, Inc Market Withdrawal of Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm-Baxter SA Recall of NucliSens Automated Isolation Reagents for Use with NucliSens HIV-1 QT - bioMerieux bv Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, Inc Recall of Ortho Assay Software (OAS) Version 2.0 (For Use with the Ortho Summit Sample Handling System)-Ortho Clinical Diagnostics, Inc Recall of MTS Anti-IgG Card and MTS A/B/D Monoclonal and Reverse Grouping Card-Micro Typing Systems, Inc Recall of Rabies Vaccine (Human Diploid Cell), Imovax Rabies-Aventis Pasteur Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine-MMWR Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm-Aventis Behring L.L.C. Recall of Allergenic Extracts - Hollister-Stier Laboratories LLC Recall of Blood Bank Data Management System Software - Information Data Management
Recalls & Alerts
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